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Re: walldiver post# 3362

Thursday, 05/10/2007 1:06:19 PM

Thursday, May 10, 2007 1:06:19 PM

Post# of 12660
<< first step would be to persuade the FDA to give them a free look at 9902B >>

Elan and Wyeth have a situation where they take peeks at their AAB-001 PII trial in progress through a neutral third party. Neither Elan nor Wyeth are allowed to see any of the data. The third company reports out the results of the peeks allowing Elan and Wyeth to see whether they have found the optimum dose/frequency of AAB-001 to determine when they should move on to a PIII trial.

I don't know if there is a penalty for the peeks in this case since, while the data is unblinded, the companies are still, essentially, blind.

Anybody know if a neutral third party looked at the 9902B data whether or not the FDA would allow them a free look?

Thurly
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